Linperlisib Combination With Obinutuzumab Frontline Treatment of Marginal Zone Lymphoma Patients (MZL)
NCT06592170 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2024-09-19
Summary
This is a single arm, open label, national multicenter clinical study included patients with marginal zone lymphoma patients (MZL) , aim is to evaluate the efficacy and safety of first-line treatment with Linperlisib combined with obinutuzumab in patients with marginal zone lymphoma (MZL).
Conditions
Interventions
- DRUG
-
Linperlisib combination with obinutuzumab
Safe import period: Linperlisib: 80 mg, oral (pre - and post meal), QD; obinutuzumab: 1000 mg, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there is one cycle in total. Extended treatment period: Combination induction: Linperlisib: RP2D, oral (pre - and post meal), QD; obinutuzumab: 1000 mg/time, intravenous infusion, administered on the first day (1st cycle on days 1, 8, and 15); Every 28 days, there are 2 cycles in total. Afterwards, single drug maintenance: Linperlisib: RP2D, oral (before and after meals), QD; every 28 days per cycle.
Sponsors & Collaborators
-
The First Hospital of Jilin University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-13
- Primary Completion
- 2025-08-13
- Completion
- 2027-08-13
Countries
- China
Study Locations
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